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Data suggest lower risk of cardiovascular events or deaths in prostate cancer patients treated with degarelix compared to LHRH agonists

Saint-Prex, Switzerland - 17 March 2013 – Data presented today at the European Association of Urology (EAU) 2013 annual meeting in Milan, indicate that the gonadotropin releasing hormone (GnRH) antagonist degarelix (brand name: FIRMAGON®) may be associated with lower risk of a cardiovascular (CV) event or death compared to commonly prescribed luteinising hormone-releasing hormone (LHRH) agonists.1 These data are based on a pooled analysis of 2,328 men with prostate cancer from six prospective, randomised trials. Analysis of the data also revealed that the men in the studies treated with FIRMAGON had significantly higher overall survival and improved disease control as evidenced by fewer fractures and a lower incidence of renal or urinary tract adverse events compared to men treated with LHRH agonists.2

Risk of CV events or deaths
Concerns about the cardiovascular toxicity of LHRH agonists have been raised following the October 2010 warning by the US Food and Drug Administration (FDA) about an increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, and stroke). The FDA based its warning on the review of several published studies.3

In the data presented at the EAU congress, results were pooled and retrospectively analysed from six prospective, comparative trials of 2,328 patients randomised to receive FIRMAGON (n=1,491) or an LHRH agonist (goserelin, n=458; leuprolide, n=379). Both treatment groups were well balanced for baseline characteristics and history of CV disease (CVD). Characteristics associated with CVD (e.g. statin medication, elevated blood pressure, diabetes, cholesterol >6.2mmol/L) were also similar between groups. The CV event analysis was based on death from any cause or a serious CV event (life-threatening or requiring hospitalisation). CV events were defined as arterial, embolic / thrombotic; haemorrhagic / ischemic cerebrovascular; myocardial infarction or other ischemic heart disease, whatever came first. A time to event analysis for patients with baseline CVD demonstrated that the risk of a serious CV event or death was significantly lower for those men receiving FIRMAGON, compared to those receiving an LHRH agonist during the first year of treatment (p=0.0066 based on the log-rank test). 

“Our findings suggest that prostate cancer patients with a history of CVD treated with degarelix have a decreased incidence of a serious CV event or death during the first year of therapy compared to treatment with an LHRH agonist”, pointed out study investigator Professor Bertrand Tombal from the Cliniques Universitaires Saint Luc, Brussels. “These results are from a pooled analysis of prospective randomized trials. Although preliminary, healthcare professionals starting patients on androgen deprivation therapy should be aware of these important findings, including the fact that the observed difference in cardiovascular risk in patients with baseline CVD was approximately 50 percent lower for Firmagon vs. LHRH agonists.”

Renal, urinary tract and musculoskeletal adverse events (AEs)
The treatment groups were also analysed for differences in adverse events from the musculoskeletal, renal and urinary systems. Findings from the pooled analysis showed that
men treated with FIRMAGON had significantly fewer fractures, a lower incidence of any renal or urinary tract adverse events, and a higher overall survival compared to patients treated with LHRH Agonists.2

The overall probability of fracture and incidence of joint-related adverse events were significantly lower for FIRMAGON-treated men than those receiving an LHRH agonist, p=0.0234, and p=0.0116,[4] respectively, based on the log-rank test. The incidence of muscle or bone pain was also lower for men treated with FIRMAGON (p=0.0822).2 The probability of any renal or urinary tract AEs was significantly lower in men receiving FIRMAGON (p<0.0001).2  Overall survival during one year of treatment was significantly higher for men treated with FIRMAGON compared to those receiving LHRH agonist treatment (98.3 vs. 96.7%, p=0.0329).4

“The improvement in disease control, higher overall survival, and reduction in musculoskeletal, renal and urinary system adverse events observed for prostate cancer patients treated with degarelix compared to LHRH agonist treatment, should be taken into consideration when considering treatment options for patients”, said Professor Kurt Miller, from Charité-Universitätsmedizin, Berlin.


- ENDS -


About FIRMAGON®
FIRMAGON® has chemical characteristics and a novel mechanism of action, different from traditionally used hormonal therapies. Administered as a deep subcutaneous injection, FIRMAGON® rapidly reduces levels of testosterone by blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the release of the luteinising hormone and follicle-stimulating hormone, resulting in a decrease in production of testosterone by the testicles to castration levels within three days. Prostate cancer is dependent on testosterone for its growth, and reducing testosterone levels slows the growth of cancer cells.

In clinical trials, FIRMAGON® decreased the production of testosterone in a rapid and sustained way.5 6 7 FIRMAGON® also maintains the PSA control over the long term and reduces the risk of PSA progression.8

In clinical trials FIRMAGON® was generally well tolerated. Common side effects are hot flushes, injection site pain and erythema, increased weight, nasopharyngitis, fatigue and back pain.5,9

About prostate cancer
Prostate cancer is the most common form of male cancer in the western world,10 and the second leading cause of cancer death in men in some countries.11 Around 300,000 new cases of prostate cancer are diagnosed in Europe each year.12 Worldwide this figure rises to 670,000 new cases.12 For further media information and news alerts on prostate cancer please visit Ferring’s information website www.ProstateCancerLiving.com.

About Ferring
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit www.ferring.com.


For more information:

Emma Coughlan
Tonic Life Communications
Tel: +44 (0) 7896 075431
emma.coughlan@toniclc.com


Patrick Gorman
Ferring Pharmaceuticals
Tel: +41 (0) 58 301 00 53
patrick.gorman@ferring.com



© 2013 Ferring B.V.
FIRMAGON® is a trademark owned by Ferring B.V.


1 Tombal B. et al. Lower risk of cardiovascular (CV) events and death in men receiving ADT by gonadotropin releasing hormone (GnRH) antagonist, degarelix, compared with luteinising hormone-releasing (LHRH) agonists. Abstract #42, EAU 2013

2 Miller K. et al. Disease control-related outcomes from an analysis of six comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone (LHRH) agonists. Abstract #68, EAU 2013

3 http://www.fda.gov/Drugs/DrugSafety/ucm229986.htm (Accessed 08 March 2013)

4 Miller K. et al. Disease control-related outcomes from an analysis of six comparative randomised clinical trials of degarelix versus luteinising hormone-releasing hormone
(LHRH) agonists, EAU 2013, Poster #678

5 Klotz L et al. BJU Int 2008; 102:1531-1538

6 Firmagon (degarelix).  Summary of product characteristics. July 2012

7 Tombal B et al. Eur Urol 2010; 57:836-42

8 Crawford ED et al. J Urol 2011;186(3):889-897

9 Van Poppel H et al. Abstract (23.) Euro Urol Suppl 2007;6(2):28

10 University of Iowa Hospitals and Clinics. Available at: 
http://www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html
[Accessed 08 March 2013]

11 American Cancer Society. Available at: http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_statistics_for_prostate_cancer_36.asp
[Accessed 08 March 2013]

12 Male Cancer.org. Available at: http://www.malecancer.org/nnm/abouts/leaflets  [Accessed 08 March 2013]

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